An Open-label, Randomized, 4-treatment, 3-period, Crossover Interaction Study, Evaluating the Effect of Esomeprazole 40 mg, Omeprazole 80 mg or Lansoprazole 60 mg on the Pharmacodynamics and the Pharmacokinetics of Clopidogrel in Healthy Volunteers

This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Overland Park,
Kansas

Purpose:

The aim of this study is to determine if there is a pharmacological interaction between
clopidogrel and different types of proton pump inhibitors (PPIs), and if the extent of this
possible interaction would change over time.

Criteria:

Inclusion Criteria:
- Healthy males within the age of 18-45 years and females within the age of 18-55 years
with suitable veins for cannulation or repeated vein puncture. Females must be of
non-childbearing potential.
- Weight of 50-95kg, inclusive, and a BMI between 19-30 kg/m2, inclusive.
- No clinically significant abnormal findings as judged by the Investigator on
enrollment physical exam.
Exclusion Criteria:
- History of any clinically significant disease or disorder which, in the opinion of
the investigator, may either put the volunteer at risk because of participation in
the study, or influence the results or the volunteer's ability to participate in
study.
- History or presence of gastrointestinal e.g. GI ulcer, hepatic or renal disease or
any other condition known to interfere with absorption, distribution, metabolism or
excretion of drugs.
- Any clinically significant illness within 4 weeks of the first administration of
investigational product. Any medical/surgical procedure or trauma within 3 months of
the treatment period; scheduled surgery, including dental surgery within 2 weeks.

NCT ID:

NCT01147588

Primary Contact:

Principal InvestigatorKelli Craven, MDQuintiles

Backup Contact:

N/A

Location Contact:

Overland Park, Kansas United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.